A Stability Indicating Method for the Determination of the Antioxidant Sodium Bisulfite in Pharmaceutical Formulation by RP-HPLC Technique

Abstract

A stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the determination of sodium bisulfate (SB), an antioxidant, in injectable dosage form. The chromatographic separation was achieved on a Zorbax CN (250 mm × 4.6 mm, 5 μm) column, with a mobile phase consisting of a buffer mixture of 0.03 M tetrabutylammonium hydrogen sulfate, 0.01 M potassium dihydrogen orthophosphate, and acetonitrile at a ratio of 70:30 (v/v) and a flow rate of 0.7 mL/min. The eluted compound was monitored at a wavelength of 215 nm using a UV detector. The method described herein separated sodium bisulfite from all other formulation components within a run time of 10 min. The method also generated linear results over an SB concentration range of 10 to 990 μg/mL, and the limit of quantification was found to be 10 μg/mL. The stability indicating capability of the method was established by performing forced degradation experiments. The RP-HPLC method that was developed was validated according to the International Conference on Harmonization (ICH) guidelines. This method was successfully applied in the quantitative determination of SB in a stability study of Amikacin sulfate injection. The procedure described herein is simple, selective, and reliable for routine quality control analysis as well as stability testing.

Rapid measurement of hemoglobin-oxygen dissociation by leveraging Bohr effect and Soret band bathochromic shift

“…Sodium metabisulfite is a chemically stable antioxidant food additive, 42 which has been used to deoxygenate blood components. 43 Sodium metabisulfite based deoxygenation has been used to induce sickling of RBCs from individuals with SCD.…”

“…Oxyhemoglobin releases oxygen to result in deoxyhemoglobin and dissolved oxygen: HbO 2 → Hb + O 2 . Sodium bisulfate is a commonly used reducing agent that readily reacts with dissolved oxygen and is converted into sodium hydrogen sulfate: 42 2Na + + 2HSO 3 − + O 2 → 2NaHSO 4 . Scavenging of dissolved oxygen by sodium bisulfate leads to increased deoxygenation of oxyhemoglobin in the sample.…”

The effect of sodium bisulfate and coccidiostat on intestinal lesions and growth performance of Eimeria spp.–challenged broilers

“…For several chemicals such as SBS, hydrogen sulfide, and organosulfur compounds that may be derived from SBS in the digestive system, antioxidant properties are attributed. Sodium bisulfite is an inorganic compound commonly used as an antioxidant in pharmaceutical formulations ( Trivedi and Patel, 2011 ). Hydrogen sulfide (H 2 S) is an antioxidant gas transmitter that protects endothelial cells against oxidative stress.…”

Sodium Metabisulfite in Food and Biological Samples: A Rapid and Ultra-Sensitive Electrochemical Detection Method

“…In many food products, particularly fruits, vegetables, seafood, pastry, and alcoholic beverages, SMB, also known as sodium pyrosulfite (Na 2 S 2 O 5 ), is a synthetic food additive that is used as an antioxidant and antibacterial preservative [ 6 , 7 ]. Additionally, it is utilized as an excipient in the pharmaceutical sector to increase the stability of active principles [ 8 ]. High oral doses of SMB have been shown to increase cell damage indices and may have genotoxic effects on mouse tissues according to previous reports [ 9 ].…”